Study Comparing Nitrofurantoin to Fosfomycin for Acute Urinary Tract Infection in Women (AIDA-WP2)
|ClinicalTrials.gov Identifier: NCT01966653|
Recruitment Status : Active, not recruiting
First Posted : October 21, 2013
Last Update Posted : May 2, 2017
|Condition or disease||Intervention/treatment||Phase|
|Urinary Tract Infections Cystitis||Drug: nitrofurantoin Drug: fosfomycin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomised Clinical Trial Comparing Fosfomycin vs. Nitrofurantoin for Treatment of Uncomplicated Lower Urinary Tract Infection in Female Adults at Increased Risk of Antibiotic-resistant Bacterial Infection|
|Actual Study Start Date :||October 2013|
|Estimated Primary Completion Date :||May 2017|
|Estimated Study Completion Date :||August 2017|
Active Comparator: nitrofurantoin
Nitrofurantoin will be given orally at a dose of 100 mg three times daily for 5 days.
nitrofurantoin 100 mg po tid for 5 days
Active Comparator: fosfomycin
A single 3g dose of oral fosfomycin will be given.
fosfomycin 3g po single dose
Other Name: Monuril
- Number of participants with clinical cure, clinical failure, or indeterminate clinical response (see description below) [ Time Frame: at 28 days post therapy completion ]Clinical response is defined as either (1) clinical cure, which in turn is defined as complete resolution of symptoms with no recurrence of symptoms or signs of urinary tract infection; (2) clinical failure, defined as the need for additional, or change in, antibiotic treatment due to a urinary tract infection, OR discontinuation due to lack of efficacy; or (3) indeterminate response, defined as either persistence of symptoms without objective evidence of infection (absence of bacteriuria or pyuria) OR any extenuating circumstances precluding a classification or clinical cure/failure.
- Number of participants with bacteriologic cure and with bacteriologic recurrence [ Time Frame: at 28 days post therapy completion ]Bacteriologic response is defined as either (1) bacteriologic cure, that is, eradication of the infecting strain with no recurrence of bacteriuria (<10x3 cfu/mL) during follow-up; or (2) bacteriologic recurrence, defined as bacteriuria >10x3 cfu/mL. However, bacteriologic recurrence without urinary tract symptoms will be designated asymptomatic bacteriuria and left untreated.
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: within 28 days post therapy completion ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01966653
|Tel Aviv University|
|Tel Aviv, Israel|
|Lodz University Hospital|
|University Hospitals of Geneva|
|Geneva, Switzerland, 1201|
|Principal Investigator:||Stephan Harbarth, MD, MS||University of Geneva|